Biogen has withdrawn the application anti-amyloid Alzheimer's drug Aduhelm from Europe's regulatory agency.
Biogen has abandoned its application for the approval of anti-amyloid Alzheimer’s therapy Aduhelm (aducanumab) with European regulatory agencies. This marks yet another setback arises for Aduhelm, which recently had its insurance coverage restricted by the Centers for Medicare and Medicaid Services in the U.S.
After the original European Medicines Agency (EMA) application failed to receive approval in December 2021, the company had re-submitted the application for review and requested for re-examination. Now, Biogen has announced that they have withdrawn Aduhelm’s application from the EMA, after it was indicated that the data would not be sufficient to approve the drug.
“We stand by the safety and efficacy of aducanumab, and we look forward to upcoming data readouts to continue to provide important information on the science of this new class of compound,” said Dr. Priya Singhal, the head of global safety and regulatory sciences and interim head of research and development at Biogen.
“Results from the main studies were conflicting and did not convincingly show that Aduhelm was effective at treating adults with early-stage Alzheimer’s disease,” the EMA wrote. “In addition, the studies did not show that the medicine was sufficiently safe.”
Despite receiving an approval from the Food and Drug Administration (FDA), Aduhelm has been riddled with controversy around its efficacy. In February of this year, the Centers for Medicare and Medicaid Services (CMS) released a confusing proposal to dramatically limit insurance coverage for Aduhelm, the anti-amyloid drug developed by Eisai and Biogen. As a result, patients have hit snag after snag in terms of both access and insurance coverage.